Senior Clinical Study Manager - Remote

Overview

The Senior Clinical Study Manager provides leadership in the planning, design, and execution of clinical studies sponsored by Penumbra to assess safety and effectiveness of products.

In Short

• Leads planning and execution of clinical studies.
• Interfaces with internal and external stakeholders.
• Develops and maintains project timelines.
• Manages regulatory documentation and audit readiness.
• Negotiates study budgets with sites and vendors.
• Monitors study progress and implements corrective actions.
• Participates in system user acceptance testing.
• Mentors and trains staff on protocols and processes.
• Contributes to process improvements for continuous enhancement.
• Ensures adherence to quality management systems and regulations.

Requirements

• Bachelor's degree in Biological Sciences or related field.
• 7+ years of clinical trial experience.
• Project management experience with complex trials.
• Familiarity with clinical study regulations (CFR, GCP/ICH).
• Proficiency in Microsoft Office and study management systems.
• Excellent organizational and communication skills.
• Ability to solve problems creatively and manage multiple projects.
• Field experience preferred in regulated industries.
• Working knowledge of medical terminology.
• Attention to detail and accuracy.

Benefits

• Opportunity to lead significant clinical studies.
• Work with a diverse team across various functions.
• Engagement with key opinion leaders at scientific conferences.
• Potential for professional growth and development.
• Involvement in continuous improvement initiatives.